FDA approved peptides in 2026: a status table with dates and sources
Which peptides have an FDA-approved product, which are investigational and which have neither, as of October 21, 2026. Every row carries a date and a primary source, with short answers for ipamorelin and BPC-157.
FDA has approved many peptide drugs, but approval always belongs to a named product from a named company, never to a molecule sold under a generic name. As of October 21, 2026, bremelanotide, setmelanotide, octreotide and the other peptides in the first table below have FDA-approved products. Ipamorelin and BPC-157 do not: neither has an approval or a sponsor program in late-stage US trials. Every row below gives a status, a date and the primary source it was read from.
What counts as an FDA-approved peptide?
Approved means Drugs@FDA lists a product whose active ingredient is that molecule, with an application number and an approval date. The approval belongs to that product and its sponsor. A vial of the same sequence from a research supplier is not that product and is not covered by it.
Investigational means a company is running registered trials and has not received an approval. Research vials sold under the same name are not the trial drug.
Neither means no product in Drugs@FDA and no sponsor-run US program. Many of these molecules were nominated for FDA's 503A bulks list, which governs pharmacy compounding and is a separate question from approval; it is explained in Category 1, Category 2 and the 503A bulks list.
Where FDA draws the size line matters for which pathway a molecule takes. Under 21 CFR 600.3(h)(6), "A protein is any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size." Chains of 40 residues or fewer are regulated as drugs, which is why the table below leaves out insulins and other proteins.
FDA approved peptide drugs list (as of October 2026)
The first five rows are the molecules asked about most on a research catalog; the rest are long-established peptide drugs, included so the list is not read as complete for one shelf only. Every date is the original approval date in Drugs@FDA, read on October 21, 2026.
| Peptide | Approved product and application | Sponsor in Drugs@FDA | First approved | Primary source |
|---|---|---|---|---|
| Sermorelin | Geref, NDA 020443; marketing status Discontinued, with a Federal Register determination that it "was not discontinued or withdrawn for safety or effectiveness reasons" | EMD Serono | September 26, 1997 | Drugs@FDA 020443 |
| Bremelanotide (PT-141) | Vyleesi, NDA 210557 | Cosette | June 21, 2019 | Drugs@FDA 210557 |
| Afamelanotide (Melanotan I) | Scenesse, NDA 210797 | Clivunel | October 8, 2019 | Drugs@FDA 210797 |
| Elamipretide (SS-31) | Forzinity, NDA 215244 | Stealth BioTherapeutics | September 19, 2025 | Drugs@FDA 215244 |
| Setmelanotide | Imcivree, NDA 213793 | Rhythm | November 25, 2020 | Drugs@FDA 213793 |
| Octreotide | Sandostatin, NDA 019667 | Novartis | October 21, 1988 | Drugs@FDA 019667 |
| Leuprolide | Lupron Depot, NDA 019732 | AbbVie | January 26, 1989 | Drugs@FDA 019732 |
| Bivalirudin | Angiomax, NDA 020873 | Sandoz | December 15, 2000 | Drugs@FDA 020873 |
| Teriparatide | Forteo, NDA 021318 | Eli Lilly | November 26, 2002 | Drugs@FDA 021318 |
| Linaclotide | Linzess, NDA 202811 | AbbVie | August 30, 2012 | Drugs@FDA 202811 |
| Vasopressin | Vasostrict, NDA 204485 | Par (PH Health) | April 17, 2014 | Drugs@FDA 204485 |
| Abaloparatide | Tymlos, NDA 208743 | Radius | April 28, 2017 | Drugs@FDA 208743 |
Apart from Geref, each application above has at least one product that Drugs@FDA lists as marketed rather than discontinued.
Which peptides are investigational, with no approval yet?
Some GLP-1 class compounds sold on research shelves are investigational: a sponsor is running registered trials, and no product has been approved. A research vial sold under a catalog code is a catalog item with a sequence, a certificate and a lot number. It is not the sponsor's trial material and carries no approval.
Which peptides have no FDA approval?
As of October 21, 2026, none of the rows below has a product in Drugs@FDA. "Withdrawn" means the nominator pulled its 503A nomination, which FDA's Category 2 page (content current April 22, 2026) records under "nominated but withdrawn"; it is a procedural event, not a safety clearance, and it leaves the substance in no category and off the 503A bulks list.
| Peptide | Status | Key date | Primary source |
|---|---|---|---|
| BPC-157 | Not approved; 503A nomination withdrawn; not in Category 1; FDA staff proposed it not be listed | Category 2 from September 29, 2023; withdrawn April 22, 2026; PCAC July 23, 2026 | FDA Category 2 page; FDA 503A PDF, May 14, 2026; PCAC briefing document |
| Ipamorelin | Not approved; still in 503B Category 2; 503A nomination withdrawn | 503B Category 2 since September 29, 2023 | FDA Category 2 page |
| TB-500 (LKKTETQ), KPV, MOTS-c, Semax, epitalon, DSIP (emideltide) | Not approved; 503A nominations withdrawn; FDA staff proposed that none be added to the 503A bulks list | Withdrawn April 22, 2026; PCAC July 23-24, 2026 | FDA Category 2 page; PCAC briefing document |
| Melanotan II | Not approved; withdrawn | Category 2 from September 29, 2023; withdrawn April 22, 2026 | FDA Category 2 page |
| Kisspeptin-10 | Not approved; still in 503A Category 2 | Added September 29, 2023 | FDA Category 2 page |
| CJC-1295, Selank ("Selank acetate (TP-7)"), AOD-9604, thymosin alpha-1 | Not approved; listed as withdrawn | Outside Category 2 by September 27, 2024 | FDA Category 2 page and its 2024 archive |
| GHK-Cu | No drug approval; 503A Category 1, except for one route FDA singled out; PCAC consultation planned | Re-added after May 5, 2026; PCAC before end of February 2027 | FDA 503A PDF, May 14, 2026 |
| NAD+ (not a peptide) | No approved product; 503A Category 1 as "Nicotinamide Adenine Dinucleotide (NAD)" | 503A list updated May 14, 2026 | FDA 503A PDF |
| 5-amino-1MQ (not a peptide) | No approval; on no 503A or 503B category list | Checked October 2026 | FDA 503A PDF; FDA 503B PDF, March 21, 2025 |
At the July 23-24, 2026 meeting of FDA's Pharmacy Compounding Advisory Committee, press reports gave majority votes in favor of listing six of the seven peptides FDA presented, with emideltide voted down. Those tallies are press figures; FDA's meeting page, content current August 6, 2026, carries no vote record, and the Federal Register shows no proposed rule on any of them as of October 21, 2026. Sport is a separate system again: WADA's 2026 Prohibited List names BPC-157 in S0 and ipamorelin, CJC-1295 and sermorelin in S2.2.4, regardless of FDA status.
Why an approved product and a research vial are not the same thing
Approval attaches to an application: a named sponsor, a manufacturing process, a specification, a label. Geref's 1997 approval belongs to EMD Serono's product, and that product is discontinued. It says nothing about a vial of sermorelin sold as a research reagent, which is what we stock. The same is true of Vyleesi and a research vial of bremelanotide, and of Forzinity and a vial labelled SS-31.
Frequently asked questions
What peptides are FDA approved in 2026?
As of October 21, 2026, approved peptide drugs include bremelanotide, afamelanotide, elamipretide, setmelanotide, octreotide, leuprolide, bivalirudin, teriparatide, linaclotide, vasopressin and abaloparatide. Sermorelin was approved as Geref in 1997 and is now discontinued. Each approval belongs to the named product in the table.
Is ipamorelin FDA approved?
No. There is no ipamorelin product in Drugs@FDA. Helsinn ran Phase 2 trials (NCT01280344 and NCT00672074, both completed), and no application has been approved.
What is ipamorelin's FDA status for compounding?
Ipamorelin acetate has been in 503B Category 2 since September 29, 2023, and it is still listed there on FDA's page dated April 22, 2026. Its 503A nomination was withdrawn. It is not in Category 1.
What is BPC-157's FDA status?
BPC-157 is not FDA approved. It was in 503A Category 2 from September 29, 2023 until its nominations were withdrawn, reflected on April 22, 2026, and it is not in Category 1 or on the 503A bulks list. FDA staff proposed in July 2026 that it not be added, and as of October 21, 2026 FDA has published no rule. The dated detail is in BPC-157 legal status in 2026.
Does an approved drug's approval cover a research peptide with the same sequence?
No. Approval covers the sponsor's product made under its application. A research vial of the same molecule is a different article with its own certificate, and it carries no approval.
Sources
- Drugs@FDA database, FDA, read October 21, 2026 (application pages linked in the table)
- 21 CFR 600.3, definitions (protein, paragraph (h)(6)), eCFR, current October 2026
- Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, FDA, content current April 22, 2026
- Same FDA page as archived September 28, 2024 (content current September 27, 2024), Internet Archive
- Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (PDF), FDA, updated May 14, 2026
- FDA committee votes on peptides (press report of the July 2026 tallies), TIME, July 23, 2026
- 503B bulk drug substance categories (PDF), FDA, updated March 21, 2025
- Pharmacy Compounding Advisory Committee meeting, July 23-24, 2026, FDA, content current August 6, 2026
- PCAC Briefing Document, Introduction (PDF), FDA, July 2026
- Federal Register documents mentioning BPC-157, federalregister.gov, searched October 21, 2026
- The 2026 Prohibited List (PDF), World Anti-Doping Agency, valid January 1, 2026
For laboratory research use only. Not a drug, not a supplement, and nothing here is a claim about what any of this material does in a person or an animal.
